Shield
Therapeutics plc
("Shield"
or the "Company" or the "Group")
Results from Phase 3
paediatric study
Pivotal Trial of
ACCRUFeR®/FeRACCRU® (ferric maltol) in Paediatric Patients with
Iron Deficiency Anemia (IDA)
proves highly clinically
relevant effectiveness
Data will be used
to support filing obligations with the US FDA and the European
EMA for a paediatric indication in
children older than 1 month for ACCRUFeR®/FeRACCRU® in H1
2025
London, UK, 25 September 2024: Shield Therapeutics plc (LSE: STX), the commercial stage
pharmaceutical company specialising in iron deficiency, announces
results from the Phase 3 paediatric clinical trial
(FORTIS/ST10-01-305), confirming the efficacy, safety, and
tolerability of the new oral liquid paediatric suspension in
children with iron deficiency anaemia (IDA).
This trial is the final study in the
comprehensive development program supporting the paediatric
investigation plan (PIP/PSP) agreed with the European EMA and the
US FDA. The full data set, including pharmacokinetic (PK) sub-study
parameters, will be submitted for peer-review and subsequent
presentation/publication. The data will be used to support a filing
with the US FDA and European EMA for a paediatric indication in
children older than 1 month for ACCRUFeR®/FeRACCRU® in H1
2025.
Additionally, Shield is due a total
of €1 million as development milestones from its European partner,
Norgine BV, upon the compliance notification of the PIP by the
Pediatric Committee (PDCO) and the granting of the paediatric
indication by EMA.
All primary endpoints were met, and
the outcomes were:
·
Change in Hb
concentration from baseline to week 12: Patients in the ferric maltol group demonstrated a highly
clinically relevant mean change in Hb concentration at week 12
compared to baseline.
o The
mean change was 1.25 g/dl from baseline to week 12 in the 2 -
17-year-old cohort and was 1.77 g/dl from baseline to week 12 in
the infants
o The
mean change was 1.15 g/dl from baseline to week 12 in patients in
the ferrous sulphate group.
·
Frequency of
discontinuations from the study because of Treatment Emergent
Adverse Events (AEs): No
patients in the ferric maltol group discontinued from the study as
a result of AEs.
o In
the 2 - 17-year-old cohort, no patient
(0/31; 0%) discontinued the ferric maltol treatment due to an AE
compared to one patient (1/30; 3.3%) who discontinued from the
ferrous sulphate arm.
o None
of the infants discontinued ferric maltol treatment due to an
AE.
·
Frequency of
AEs/serious adverse events (SAEs): No patient in the ferric maltol group reported a treatment
related SAE and two (2) patients reported treatment related
AEs.
o No
treatment related SAEs were reported in either
group.
o In
the 2 - 17-year-old cohort, treatment
related AEs were reported in 2 out of 31 patients treated with
ferric maltol compared to 4 out of 30 patients treated with ferrous
sulphate.
o None
of the ferric maltol-treated infants reported treatment related AEs
.
Anders Lundstrom, interim CEO commented:
"We are
delighted that the results in this important ACCRUFeR®/FeRACCRU®
Paediatric Phase 3 study show similar levels of efficacy and safety
as in prior trials with adults. We will now initiate the work with
the regulatory applications to be able to expand the patient
population who can benefit from a safe and effective oral iron
treatment."
Professor Richard Russell, a FORTIS Principal Investigator,
commented: "These results indicate that the newly
developed paediatric liquid formulation will provide a welcome
additional well-tolerated and effective therapeutic option for the
treatment of IDA in young children and
adolescents."
For
further information please contact:
Shield Therapeutics plc
|
www.shieldtherapeutics.com
|
Anders Lundstrom, CEO
Santosh Shanbhag, CFO
|
+44 (0)
191 511 8500
|
Nominated Adviser and Joint Broker
|
|
Peel Hunt LLP
|
|
James Steel/Patrick
Birkholm
|
+44 (0)20
7418 8900
|
|
|
Joint Broker
Cavendish Ltd
Geoff Nash/ Rory Sale/Nigel
Birks/Harriet
Ward
|
+44 (0)20
7220 0500
|
|
|
Financial PR & IR Advisor
|
|
Walbrook PR
|
|
Charlotte Edgar / Alice
Woodings
|
+44 (0)20
7933 8780 or shield@walbrookpr.com
|
About Iron Deficiency and
ACCRUFeR®/FeRACCRU®
Clinically low iron levels (aka iron
deficiency, ID) can cause serious health problems for adults of all
ages, across multiple therapeutic areas. Together, ID and ID with
anemia (IDA) affect about 20 million people in the US and represent
a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, ACCRUFeR® has the potential to meet an
important unmet medical need for both physicians and
patients.
ACCRUFeR®/FeRACCRU® (ferric maltol)
is a novel, stable, non-salt-based oral therapy for adults with
ID/IDA. The drug has a novel mechanism of absorption compared to other oral
iron therapies and has been shown to be an efficacious and
well-tolerated therapy in a range of clinical trials. More
information about ACCRUFeR®/FeRACCRU®, including the product
label, can be found at: www.accrufer.com and www.feraccru.com.
About Shield Therapeutics plc
Shield is a commercial stage
specialty pharmaceutical company that delivers ACCRUFeR®/FeRACCRU®
(ferric maltol), an innovative and differentiated pharmaceutical
product, to address a significant unmet need for patients suffering
from iron deficiency, with or without anemia. The Company has launched ACCRUFeR® in the U.S. with an
exclusive, multi-year collaboration agreement with Viatris. Outside
of the U.S., the Company has licensed the rights to four specialty
pharmaceutical companies. FeRACCRU® is commercialized in the UK and
European Union by Norgine B.V., which also has marketing rights in
Australia and New Zealand. Shield also has an exclusive license
agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the
development and commercialization of ACCRUFeR®/ FeRACCRU® in China,
Hong Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the
Republic of Korea, and with KYE Pharmaceuticals Inc. for
Canada.
ACCRUFeR®/FeRACCRU® has patent
coverage until the mid-2030s.
ACCRUFeR®/FeRACCRU® are registered
trademarks of Shield Therapeutics.
Forward-Looking Statements
This press release contains
forward-looking statements. All statements contained in this press
release that do not relate to matters of historical fact should be
considered forward-looking statements. These forward-looking
statements are based on management's current expectations and
include statements related to the commercial strategy for
ACCRUFeR®/FeRACCRU®. These statements are neither promises nor
guarantees, but involve known and unknown risks and uncertainties,
many of which are beyond our control, that may cause actual results
and performance or achievements to be materially different from
management's expectations expressed or implied by the
forward-looking statements, including, but not limited to, risks
associated with the Company's business and results of operations,
competition and other market factors. The forward-looking
statements made in this press release represent management's
expectations as of the date of this press release, and except as
required by law, the Company disclaims any obligation to update any
forward-looking statements contained in this release, even if
subsequent events cause its views to change.
Details of the FORTIS/ST10-01-305 Phase 3
study
The open label randomized Phase 3
study included children aged 1 month to 17 years with mild to
moderate iron-deficiency anaemia (IDA), who also had serum ferritin
levels below 30 μg/L or ferritin levels below 50 μg/L and
transferrin saturation below 20%. Children aged 2 to 17 years
were randomized 1:1 to receive either ferric maltol (N=31) or
ferrous sulphate (N = 30). Children 1 month to under 2
years (N=4, and 3 were treated) were all assigned
to receive ferric maltol treatment. The study was not powered
to detect a statistical difference in primary endpoints between
ferric maltol and the ferrous sulphate comparator
group.